AUSTrian Randomized Interventional Study on Dialysis Accesses

Not Applicable

• Conditions: End Stage Renal Disease; Shunt Malfunction; Catheter Infection
• Interventions: Device: Arteriovenous Fistula; Device: Tunneled Cuffed Catheter

• Registration Number: NCT03764358
• Lead Sponsor: Medical University of Vienna

Brief Summary

Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index \>6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05
• Study Start: 2019-03-06
• Primary Completion: 2022-04-04
• Study Completion: 2022-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Age of 60 and higher
• CCI Score >6 when under 60 years
• Patients with CKD G5 A1-3 with indication for hemodialysis
• Stable clinical condition
• Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
• Availability for follow-up.
• Written informed consent.

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Exclusion Criteria

• Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening.
• Poor general condition of health or malignancy not in remission at screening
• Major surgery within 12 weeks before screening.
• Pre-existent vascular access.
• Patient not eligible for any one of the vascular access options.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arteriovenous fistula	Arteriovenous Fistula	-
Tunneled Cuffed Catheter	Tunneled Cuffed Catheter	-

Primary Outcome Measures

Name	Time	Method
Composite primary end-point of any access related complication	From placement of vascular access through study completion, an average of 3 years.	Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis

Trial Locations

Locations (1)

Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna; 🇦🇹 Vienna, Austria